Cleanrooms and associated controlled environments - Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration (ISO 14644-2:2015)

This part of ISO 14644 specifies minimum requirements for a monitoring plan for cleanroom or clean
zone performance related to air cleanliness by particle concentration, based upon parameters that
measure or affect airborne particle concentration.
This part of ISO 14644 does not address condition monitoring of aspects such as vibration or general
maintenance of the engineering systems. It does not provide for monitoring of particle populations
that are outside the specified lower threshold particle-size range, 0,1 μm to 5 μm. Concentrations of
ultrafine particles (particles smaller than 0,1μm) will be addressed in a separate standard.

Reinräume und zugehörige Reinraumbereiche - Teil 2: Überwachung zum Nachweis der Reinraumleistung bezüglich Luftreinheit anhand der Partikelkonzentration (ISO 14644-2:2015)

Dieser Teil der ISO 14644 legt Anforderungen an die regelmäßige Prüfung eines Rein¬raumes oder reinen Bereiches zum Nachweis der fortlaufenden Übereinstimmung mit ISO 14644-1 hinsichtlich der bezeichneten Klassifizierung der Partikelreinheit der Luft fest.
Diese Anforderungen beziehen sich auf die in ISO 14644-1 beschriebene Prüfung zur Klassifizierung eines Reinraumes oder eines reinen Bereiches.
Darüber hinaus werden zusätzliche Prüfungen festgelegt (5.2), die nach den Anforderungen dieses Teils von ISO 14644 durchzuführen sind.
Dieser Teil der ISO 14644 legt außerdem Anforderungen an die Überwachung eines Reinraumes oder reinen Bereiches zum Nachweis der fortlaufenden Übereinstimmung mit ISO 14644-1 hinsichtlich der bezeich¬neten Klassifizierung der Partikelreinheit der Luft fest.

Salles propres et environnements maîtrisés apparentés - Partie 2: Surveillance du maintien des performances de la salle propre pour la propreté particulaire de l'air (ISO 14644-2:2015)

ISO 14644-2:2015 spécifie les exigences minimales d'un plan de surveillance des performances d'une salle propre ou d'une zone propre en lien avec la propreté particulaire de l'air, d'après des paramètres qui mesurent ou modifient la concentration de particules en suspension dans l'air.
ISO 14644-2:2015 ne traite pas de la surveillance de l'état dans lequel se trouvent d'autres aspects tels que les vibrations ni de la maintenance générale des systèmes techniques. Elle ne traite pas de la surveillance des populations de particules dont le seuil inférieur se situe en dehors de l'étendue granulométrique de référence de 0,1 µm à 5 µm. Les concentrations de particules ultrafines (plus petites que 0,1 µm) seront traitées dans une norme séparée.

Čiste sobe in podobna nadzorovana okolja - 2. del: Nadzor za dokazovanje lastnosti čistih sob v povezavi s čistostjo zraka na osnovi koncentracije delcev (ISO 14644-2:2015)

Ta del standarda ISO 14644 določa minimalne zahteve za načrt nadzora lastnosti čiste sobe ali čistega območja v zvezi s čistostjo zraka na osnovi koncentracije delcev, ki temelji na parametrih za merjenje ali vplivanje na koncentracijo delcev v zraku.
Ta del standarda ISO 14644 ne obravnava nadzora stanja z vidika vibracij ali splošnega vzdrževanja inženirskih sistemov. Standard ne zajema nadzora populacij delcev, ki so zunaj določenega mejnega razpona velikosti delcev od 0,1 μm do 5 μm. Koncentracije ultra finih delcev (delcev, manjših od 0,1 μm) bodo obravnavane v ločenem standardu.

General Information

Status
Published
Public Enquiry End Date
24-Apr-2011
Publication Date
26-Jan-2016
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
06-Jan-2016
Due Date
12-Mar-2016
Completion Date
27-Jan-2016

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SLOVENSKI STANDARD
SIST EN ISO 14644-2:2016
01-marec-2016
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SIST EN ISO 14644-2:2001
ýLVWHVREHLQSRGREQDQDG]RURYDQDRNROMDGHO1DG]RU]DGRND]RYDQMH
ODVWQRVWLþLVWLKVREYSRYH]DYLVþLVWRVWMR]UDNDQDRVQRYLNRQFHQWUDFLMHGHOFHY
,62

Cleanrooms and associated controlled environments - Part 2: Monitoring to provide

evidence of cleanroom performance related to air cleanliness by particle concentration

(ISO 14644-2:2015)
Reinräume und zugehörige Reinraumbereiche - Teil 2: Überwachung zum Nachweis der

Reinraumleistung bezüglich Luftreinheit anhand der Partikelkonzentration (ISO 14644-

2:2015)

Salles propres et environnements maîtrisés apparentés - Partie 2: Surveillance du

maintien des performances de la salle propre pour la propreté particulaire de l'air (ISO

14644-2:2015)
Ta slovenski standard je istoveten z: EN ISO 14644-2:2015
ICS:
13.040.35 Brezprašni prostori in Cleanrooms and associated
povezana nadzorovana controlled environments
okolja
SIST EN ISO 14644-2:2016 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 14644-2:2016
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SIST EN ISO 14644-2:2016
EN ISO 14644-2
EUROPEAN STANDARD
NORME EUROPÉENNE
December 2015
EUROPÄISCHE NORM
ICS 13.040.35 Supersedes EN ISO 14644-2:2000
English Version
Cleanrooms and associated controlled environments - Part
2: Monitoring to provide evidence of cleanroom
performance related to air cleanliness by particle
concentration (ISO 14644-2:2015)

Salles propres et environnements maîtrisés apparentés Reinräume und zugehörige Reinraumbereiche - Teil 2:

- Partie 2: Surveillance du maintien des performances Überwachung zum Nachweis der Reinraumleistung

de la salle propre pour la propreté particulaire de l'air bezüglich Luftreinheit anhand der

(ISO 14644-2:2015) Partikelkonzentration (ISO 14644-2:2015)
This European Standard was approved by CEN on 27 November 2015.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this

European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references

concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN

member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by

translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management

Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,

Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,

Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and

United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels

© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14644-2:2015 E

worldwide for CEN national Members.
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SIST EN ISO 14644-2:2016
EN ISO 14644-2:2015 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

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SIST EN ISO 14644-2:2016
EN ISO 14644-2:2015 (E)
European foreword

This document (EN ISO 14644-2:2015) has been prepared by Technical Committee ISO/TC 209

"Cleanrooms and associated controlled environments" in collaboration with Technical Committee

CEN/TC 243 “Cleanroom technology” the secretariat of which is held by BSI.

This European Standard shall be given the status of a national standard, either by publication of an

identical text or by endorsement, at the latest by June 2016, and conflicting national standards shall be

withdrawn at the latest by June 2016.

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent

rights.
This document supersedes EN ISO 14644-2:2000.

According to the CEN-CENELEC Internal Regulations, the national standards organizations of the

following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,

Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,

France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,

Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,

Turkey and the United Kingdom.
Endorsement notice

The text of ISO 14644-2:2015 has been approved by CEN as EN ISO 14644-2:2015 without any

modification.
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SIST EN ISO 14644-2:2016
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SIST EN ISO 14644-2:2016
INTERNATIONAL ISO
STANDARD 14644-2
Second edition
2015-12-15
Cleanrooms and associated controlled
environments —
Part 2:
Monitoring to provide evidence of
cleanroom performance related to air
cleanliness by particle concentration
Salles propres et environnements maîtrisés apparentés —
Partie 2: Surveillance du maintien des performances de la salle propre
pour la propreté particulaire de l’air
Reference number
ISO 14644-2:2015(E)
ISO 2015
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SIST EN ISO 14644-2:2016
ISO 14644-2:2015(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2015, Published in Switzerland

All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form

or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior

written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of

the requester.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2015 – All rights reserved
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SIST EN ISO 14644-2:2016
ISO 14644-2:2015(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

Introduction ..................................................................................................................................................................................................................................v

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 Creating, implementing and maintaining a monitoring plan ................................................................................ 2

4.1 Principle ........................................................................................................................................................................................................ 2

4.2 Risk assessment ..................................................................................................................................................................................... 2

4.3 Monitoring plan ...................................................................................................................................................................................... 3

4.4 Calibration .................................................................................................................................................................................................. 3

4.5 Review and approval.......................................................................................................................................................................... 4

4.6 Response to a deviation during monitoring .................................................................................................................. 4

5 Periodic classification of air cleanliness by particle concentration ...............................................................4

Annex A (informative) Matters to consider when developing a monitoring plan .................................................5

Annex B (informative) Considerations for setting alert and action levels ....................................................................9

Bibliography .............................................................................................................................................................................................................................14

© ISO 2015 – All rights reserved iii
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SIST EN ISO 14644-2:2016
ISO 14644-2:2015(E)
Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards

bodies (ISO member bodies). The work of preparing International Standards is normally carried out

through ISO technical committees. Each member body interested in a subject for which a technical

committee has been established has the right to be represented on that committee. International

organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.

ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of

electrotechnical standardization.

The procedures used to develop this document and those intended for its further maintenance are

described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the

different types of ISO documents should be noted. This document was drafted in accordance with the

editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of

any patent rights identified during the development of the document will be in the Introduction and/or

on the ISO list of patent declarations received (see www.iso.org/patents).

Any trade name used in this document is information given for the convenience of users and does not

constitute an endorsement.

For an explanation on the meaning of ISO specific terms and expressions related to conformity

assessment, as well as information about ISO’s adherence to the WTO principles in the Technical

Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information

The committee responsible for this document is ISO/TC 209, Cleanrooms and associated controlled

environments.

This second edition cancels and replaces the first edition (ISO 14644-2:2000), which has been

technically revised throughout.

ISO 14644 consists of the following parts, under the general title Cleanrooms and associated controlled

environments:
— Part 1: Classification of air cleanliness by particle concentration

— Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle

concentration
— Part 3: Test methods
— Part 4: Design, construction and start-up
— Part 5: Operations

— Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)

— Part 8: Classification of air cleanliness by chemical concentration (ACC)
— Part 9: Classification of surface cleanliness by particle concentration
— Part 10: Classification of surface cleanliness by chemical concentration

Attention is also drawn to ISO 14698, Cleanrooms and associated controlled environments — Bio-

contamination control:
— Part 1: General principles and methods
— Part 2: Evaluation and interpretation of bio-contamination data
iv © ISO 2015 – All rights reserved
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SIST EN ISO 14644-2:2016
ISO 14644-2:2015(E)
Introduction

This revision of ISO 14644-2 emphasizes the need to consider a monitoring strategy in addition to

the initial or periodic execution of the classification of a cleanroom or clean zone in accordance with

ISO 14644-1:2015, 5.1. The monitoring activity provides a continuing flow of data over time, thereby

providing a more detailed view of the performance of the installation.
Potential benefits gained from monitoring are
— faster response to adverse events and conditions,
— ability to develop trends from data over time,
— integration of data from multiple instruments,

— enhanced knowledge of installation and process, which allows for more effective risk assessment, and

— improved control of operational costs and product losses.

ISO 14644-2 specifies the requirements of a monitoring plan, based on risk assessment of the intended

use. The data obtained provide evidence of cleanroom or clean zone performance related to air

cleanliness by particle concentration.

In some circumstances, relevant regulatory agencies may impose supplementary policies, requirements

or restrictions. In such situations, appropriate adaptations of the monitoring procedures may be

required. After a monitoring plan is initially established and implemented, it may be necessary to

revise the plan when significant changes are made to the installation or process requirements. It is also

prudent to conduct periodic reviews of a monitoring plan based on data obtained and experience in use.

© ISO 2015 – All rights reserved v
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SIST EN ISO 14644-2:2016
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SIST EN ISO 14644-2:2016
INTERNATIONAL STANDARD ISO 14644-2:2015(E)
Cleanrooms and associated controlled environments —
Part 2:
Monitoring to provide evidence of cleanroom performance
related to air cleanliness by particle concentration
1 Scope

This part of ISO 14644 specifies minimum requirements for a monitoring plan for cleanroom or clean

zone performance related to air cleanliness by particle concentration, based upon parameters that

measure or affect airborne particle concentration.

This part of ISO 14644 does not address condition monitoring of aspects such as vibration or general

maintenance of the engineering systems. It does not provide for monitoring of particle populations

that are outside the specified lower threshold particle-size range, 0,1 µm to 5 µm. Concentrations of

ultrafine particles (particles smaller than 0,1µm) will be addressed in a separate standard.

2 Normative references

The following documents, in whole or in part, are normatively referenced in this document and are

indispensable for its application. For dated references, only the edition cited applies. For undated

references, the latest edition of the referenced document (including any amendments) applies.

ISO 14644-1:2015, Cleanrooms and associated controlled environments — Part 1: Classification of air

cleanliness by particle concentration
3 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO 14644-1 and the following apply:

3.1
test

procedure undertaken in accordance with a defined method to determine the performance of an

installation or an element thereof
3.2
monitoring

observations made by measurement in accordance with a defined method and plan to provide evidence

of the performance of an installation

Note 1 to entry: Monitoring may be continuous, sequential or periodic; and if periodic, the frequency shall be

specified.

Note 2 to entry: This information may be used to detect trends in operational state and to provide process support.

3.3
action level

level of a parameter set by the user which, when exceeded, requires immediate intervention, including

investigation of cause, and corrective action
© ISO 2015 – All rights reserved 1
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SIST EN ISO 14644-2:2016
ISO 14644-2:2015(E)
3.4
alert level

level of a parameter set by the user giving early warning of a drift from normal conditions, which, when

exceeded, should result in increased attention or corrective action
4 Creating, implementing and maintaining a monitoring plan
4.1 Principle

In order to gain assurance that a cleanroom or clean zone is performing adequately by delivering

the required control of air cleanliness by particle concentration, a monitoring plan shall be created,

implemented and maintained.

A monitoring plan shall take into account the level of air cleanliness required, critical locations and

performance attributes of the cleanroom or clean zone that affect the performance of the installation. The

following steps shall be included in the creation, implementation and maintenance of the monitoring plan:

— use appropriate risk assessment tools to understand, evaluate and document the risk of adverse

contamination events;
— develop a written monitoring plan;
— review and approve the plan;
— implement the plan by performing the monitoring;

— analyse the data derived from the monitoring activity, undertake trend analysis where appropriate

and report performance;
— implement and document actions or corrective actions required;
— undertake periodic review of the monitoring plan.

The concentration of airborne particles measured under a monitoring plan may be higher than the

concentration observed during at-rest classification. The observed values may fluctuate considerably

due to factors such as, but not limited to, the number of personnel present, the airflow rate, ventilation

effectiveness, the operation of instruments or machinery, and activities in adjacent spaces.

For processes that inherently produce particles as part of the process and where these particles are

not a threat to the process or product, it may be appropriate to rely on periodic at-rest classification,

or operational classification of simulated operations, rather than monitoring of airborne particles in

operation. Other performance and cleanliness attributes may still be required to be monitored.

4.2 Risk assessment

Risk assessment is a systematic process of identification of hazards and the analysis and evaluation of

risks associated with exposure to those hazards.
A risk assessment shall be undertaken in order to

— develop a monitoring plan by determining factors that may affect the ability to maintain the agreed

air cleanliness by particle concentration of the cleanroom or clean zone, and
— determine the monitoring requirements to provide evidence of performance.

For guidance on what to consider when undertaking a risk assessment, see informative Annex A.

2 © ISO 2015 – All rights reserved
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SIST EN ISO 14644-2:2016
ISO 14644-2:2015(E)
4.3 Monitoring plan

4.3.1 The monitoring plan shall take into account the output from the risk assessment.

When developing the monitoring plan, the factors described in 4.3.2 to 4.3.13 shall be included as a

minimum.

4.3.2 Listing and justification of all the parameters to be monitored, including those that may affect the

airborne particle concentration.

4.3.3 Description and justification of measurement methods. For further guidance on considerations

when developing a monitoring plan, see informative Annex A.
4.3.4 Accuracy, maintenance and calibration of monitoring instrumentation.

4.3.5 Identification and justification of selected monitoring locations. Monitoring locations shall be

defined in three dimensions.

4.3.6 Identification and justification of monitoring acceptance criteria or limits, including

establishment of a single alarm level, or a dual alarm approach of alert and action levels. The minimum

requirement is that a single alarm action level is established. Additionally, an alarm alert level can be

established to provide early warning of performance deviation. For further guidance on setting alert and

action levels, see informative Annex B.

4.3.7 Specification of the response required should the data fall outside the specified limits.

4.3.8 The need for and frequency of periodic cleanroom or clean zone air cleanliness classification by

particle concentration in accordance with ISO 14644-1:2015, 5.1.
4.3.9 The format for recording data.

4.3.10 The methods, including statistical methods to be used for data trending or other appropriate

analysis.
4.3.11 The reporting requirements.
4.3.12 The policy and media to be used for record retention.
4.3.13 The frequency of review of the monitoring plan.

NOTE Monitoring plans are reviewed periodically; and based on the knowledge gained about the cleanroom

or clean zone, the monitoring programme is revised.
4.4 Calibration

Instrumentation used for monitoring shall be adequate to perform the monitoring operations required,

shall have a valid calibration certificate, and shall meet current accepted practices for the frequency

and method of calibration.

In particular for airborne particle counters, the frequency and method of calibration should be based

upon current accepted practice as specified in ISO 21501-4.

NOTE Some particle counters cannot be calibrated to all of the required tests in ISO 21501-4. If this is the

case, record the decision to use the counter in the monitoring plan.
© ISO 2015 – All rights reserved 3
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SIST EN ISO 14644-2:2016
ISO 14644-2:2015(E)
4.5 Review and approval
The completed plan shall be reviewed and approved.
4.6 Response to a deviation during monitoring

If monitoring results exceed the specified limit(s), an investigation shall be conducted to determine

cause, and remedial action taken as required.

If the remedial action requires significant changes to the installation and/or its operation, then the

classification test according to ISO 14644-1 shall be undertaken. The monitoring plan shall also be

reviewed as a result of the changes to the installation and/or its operation.
When the desired classification has been achieved, monitoring may be resumed.
5 Periodic classification of air cleanliness by particle concentration

Periodic classification testing shall be undertaken annually in accordance with ISO 14644-1. This

frequency can be extended based on risk assessment, the extent of the monitoring system, and data

that are consistently in compliance with acceptance limits or levels defined in the monitoring plan.

NOTE ISO 14644-3 specifies ancillary tests related to other aspects of cleanroom performance such as

pressure difference, airflow, etc.
4 © ISO 2015 – All rights reserved
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SIST EN ISO 14644-2:2016
ISO 14644-2:2015(E)
Annex A
(informative)
Matters to consider when developing a monitoring plan
A.1 Risk assessment considerations
A.1.1 Selection of an appropriate risk assessment tool

Risk assessment can be undertaken using a number of tools – separately or in combination – including

but not limited to
— HACCP,
— FMEA / FMECA,
— PHA,
— FTA, and
— HAZOP.

A.1.2 Definition of required performance and operating conditions that may need to be

monitored
These can be factors such as

— understanding the contamination sources and their impact on the activity in the cleanroom or clean

zone at critical locations or at locations representative of the general air cleanliness in a cleanroom

or clean zone,

— performance of the installation that might affect the cleanliness levels such as pressure differential,

airflow uniformity, airflow volume, ventilation effectiveness, temperature, relative humidity,

— normal and energy-saving set-back mode,
— at-rest or operational states, and
— occupancy and level of activity, such as change of shift.
A.2 General considerations

A.2.1 The general matters described in A.2.2 to A.2.21 should be considered when developing a

monitoring plan.

A.2.2 The measurement technique, including the selection of manual and/or automated monitoring.

A.2.3 The resolution, accuracy and calibration requirements of the measurement system including, in

the case of airborne particle counters, the efficiency and limitations of the collection system.

A.2.4 The location of monitoring system components, including requirements for access for

maintenance and calibration.
© ISO 2015 – All rights reserved 5
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SIST EN ISO 14644-2:2016
ISO 14644-2:2015(E)
A.2.5 Instrument or sample probe location, configuration and orientation.

A.2.6 Identification of frequency of measurement or sampling in order to detect deviation events.

A.2.7 Consideration of issues that may influence the monitoring system or the results obtained, such as

(but not limited to) temperature, humidity, cleaning procedures and agents, fumigation agents, product

materials or process hazards and sources of potential convection currents in the air due to heated surfaces.

A.2.8 Consideration of any potential adverse impact of the sampling system on the process or the

process environment (e.g. possible effects of the extraction of the air-sample volume required by a

particle counter on small enclosed environments).

A.2.9 The results of any airflow visualization studies such as “smoke studies,” computer airflow

modelling simulations or other studies.

A.2.10 Understanding the ventilation effectiveness in the cleanroom or clean zone, as might be affected

by rate of air exchanges, recovery or clean-up time studies, or any other method to understand the

potential rate of removal of airborne particles.

A.2.11 Extent and/or frequency of cleaning or maintenance procedures and their impact on airborne

particle levels, both during execution and immediately after completion of the procedure.

A.2.12 Consideration of process-related events that may affect environmental conditions at monitoring

locations. Such events may include (but are not limited to) dismantling, cleaning and reassembly of

equipment, whether as part of the process cycle or as an element of maintenance work.

NOTE It may be useful to include within the monitoring plan provisions for monitoring the recovery time at

the conclusion of such refitting, prior to resuming normal operations.

A.2.13 Typical positions and movements of personnel during the critical operational periods.

A.2.14 Expectations for the number of personnel active in the cleanroom or clean zone, the nature of

their occupation and the duration of their activities.

A.2.15 Assessment of the impact of equipment-generated changes to airflow patterns.

A.2.16 Assessment of the potential for equipment-generated particle sources. Examples include particles

generated from abrasion of surfaces on moving conveyor systems, and processes such as sealing of glass

ampoules and radio frequency (RF) welding of tubing.

A.2.17 Data logging and data management, including data integrity, storage and retrieval

NOTE In some industries the storage and integrity of data are specifically regulated.

A.2.18 Establishment of suitable techniques for the evaluation of raw data, assessment of trends, and

production of reports.

A.2.19 Definition of acceptance criteria and establishment of a single alarm level, or a dual approach of

alert and action levels.
A.2.20 Requirements for commissioning and testing of the monitoring system(s).
A.2.21 Requirements for maintenance of the monitoring system(s).
6 © ISO 2015 – All rights reserved
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SIST EN ISO 14644-2:2016
ISO 14644-2:2015(E)
A.3 Pressure differential monitoring

A.3.1 The additional aspects described in A.3.2 to A.3.5 should be considered for specifying monitoring

systems for differential pressures in cleanrooms or clean zones.

A.3.2 The method of minimising or managing fluctuations caused by disturbances such as door

openings or intermittent operation of local exhaust systems. A common method is the introduction of

time delays on alarms.

A.3.3 Selection of a pressure-measurement reference principle (measurement of differential pressure

between rooms or spaces, or measurement of differential against a common reference pressure).

A.3.4 Establishment of alert and action levels that are sensitive to normal pressure fluctuations due to

factors such as wind effects on buildings, the opening and closing of doors and other factors.

A.3.5 The pressure differential may be monitored by periodic observation or by automated

instrumentation.
A.4 Airborne particle monitoring system

A.4.1 The additional aspects described in A.4.2 to A.4.6 should be considered for specifying real-time

airborne particle counting systems.
A.4.2 The configuration of the system based on eva
...

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